Evaluating Pulse Oximetry Bias in Children With Darker Skin Pigmentation


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Trial ID: NCT05617547


In this prospective study, the investigators will enroll 154 children with arterial lines to determine the accuracy of pulse oximeters in children with darker skin pigmentation. Studies in adults suggest pulse oximeters may overestimate the true level of oxygenation in the blood as measured directly by co-oximetry. However, pediatric data are relatively limited. This study, which is funded by the FDA through the Stanford-UCSF (University of California San Francisco) Clinical Excellence in Regulatory Science and Innovation (CERSI) Program, will determine if the error/bias is associated with skin pigmentation and whether the error falls outside FDA standards. The broader purpose of the study is to work toward eliminating health disparities.

Official Title

Prospective Clinical Study to Evaluate the Accuracy of Pulse Oximeters in Children With Darker Skin Pigmentation

Stanford Investigator(s)


Inclusion Criteria:

   1. Age ≤21 years of age

   2. Requires arterial vascular access as part of routine clinical care

   3. Patient or legally authorized representative (LAR) willing to provide written informed

Exclusion Criteria:

   1. Anemia defined as a Hgb <8 g/dL

   2. Methemoglobinemia or carbon monoxide poisoning where the SpO2 is known to be

   3. Skin condition, such as epidermolysis bullosa, where pulse oximetry not expected to be
   accurate, or application of skin probes is medically inadvisable

   4. Non-pulsatile patients (e.g., left ventricular assist device (LVAD), extracorporeal
   membrane oxygenation (ECMO)

   5. Lack of informed consent


diagnostic test: Pulse Oximeter (Massimo)


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Christopher Almond, MD